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NCT03247335 Clinical Trial

Follow-up of Arthrosurface HemiCAP Implants

Orthopedic Disorder Clinical Trial

Official title:
Follow-up of Arthrosurface HemiCAP Implants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03247335
Other study ID # 17-341
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2018
Est. completion date August 1, 2019

Study information
Verified date March 2021
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Follow-up of Arthrosurface HemiCAP shoulder implants.

Description:

In summary, the investigators would like to contact all patients who have had HemiCAP implants done at CCF with at least 2 years of follow-up after their procedure. The investigators will use electronic or written means to alert the patients that they will be contacted by our team to discuss their surgery and any related issues. Once the appropriate consent is obtained, the investigators will use a brief telephone interview to ask the patients several questions regarding any re-operations or complications the patients have had since the index procedure.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date August 1, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: -Patients who had Arthrosurface (Franlin, MA) HemiCAP implants placed into their shoulders at the Cleveland Clinic Exclusion Criteria: - Anyone who has not had ARthrosurface (Franlin, MA) HeiCAP implants placed into their shoulders at the Cleveland Clinic

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
The Cleveland Clinic Arthrosurface, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arthrosurface survival curve for the implant 2 year
Secondary Rate of revision surgeries rate of revision surgeries 2 year
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